Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older.

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Key information

Conditions

Japanese Encephalitis Arbovirus Infections Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Encephalitis Encephalitis, Arbovirus Encephalitis, Japanese Encephalitis, Viral Flaviviridae Infections Flavivirus Infections Infections Infectious Encephalitis Mosquito-Borne Diseases Nervous System Diseases Neuroinflammatory Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

8 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

About this study

Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study. No study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings.

The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart. All participants will be observed for the incidence of any adverse events (AEs) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. Additionally, all participants will be observed for unsolicited AEs within 30 days after after each vaccination.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy children who have received the inactivated Japanese encephalitis vaccine.
Legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form.
Legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits.

Exclusion criteria

Treatment and study plan

Primary outcomes

Number of Participants Reporting Solicited Local and Systemic Adverse Events, and Unsolicited Adverse Events

Time frame: 30 days following each vaccination
Adverse events (AEs) are defined as all adverse medical events that occur in participants after receiving the investigational drug, which can manifest as symptoms, signs, diseases, or abnormal laboratory tests, but they may not necessarily have a causal relationship with the investigational drug.

Unsolicited AEs will be collected within 30 days after each dose of vaccine administration, while solicited adverse reactions will be collected within 30 minutes and 30 minutes to 7 days after each dose of vaccine administration. A structured form (pre-listed) will be used to record the local and systemic reactions collected below.

Local reactions:
- Pain
- Induration
- Ecchymosis (Redness)
- Pruritus
- Rash
Systemic reactions:
- Headache
- Courbature (not from injection site)
- Diarrhea
- Dysphagia
- Anorexia
- Vomiting
- Sickness
- Cough
- Dyspnea
- Irritability
- Sleepiness
- Acute allergic reaction
- Pain (not from injection site)

Sponsors and collaborators

Lead sponsor

Liaoning Chengda Biotechnology CO., LTD

Industry

Registry information

Official study title

Safety Observation of the Vero Cell-derived Inactivated Japanese Encephalitis Vaccine (JEV-I) Given With Primary Immunization in a Large Amount of Healthy Children Aged 8 Months and Older

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 18, 2024
Registry last updated: Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed